NL-OMON34306已完成2 期
Pharmacokinetics of anidulafungin (Ecalta ®) given intravenously as antifungal prophylaxis to recipients of an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or patients receiving intensive chemotherapy for AML-MDS who are at high risk for developing invasive fungal disease - Ecalta PK in HSCT and AML-MDS patients
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patient receives an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or receives first remission induction treatmentintensive chemotherapy for AML-MDS
- •2. Subject is at least 18 and not older than 65 years of age on the day of the first dosing
- •3. Has no signs or symptoms of invasive fungal disease
- •4. If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant
- •5. Has an ALAT, ALAT, alkaline phosphatase < 5 times the upper limit of normal and a bilirubin level < 3 times the upper limit of normal
- •6. Is not known to be hypersensitive to echinocandin antifungal agents
- •7. Is managed with a quadruple central venous catheter (Arrow-Howes* Quad- Lumen 8.5,5 French; Arrow International)
- •8. Subject is able and willing to sign the Informed Consent before screening evaluations
排除标准
- •1. Documented history of sensitivity to medicinal products or excipients similar to those found in the anidulafungin preparation
- •2. Known of Positive HIV test or hepatitis B or C test in history
- •3. History of QT time prolongation
- •4. History of or current abuse of drugs, alcohol or solvents
- •5. Inability to understand the nature of the trial and the procedures required
- •6. Has not previously participated in this trial
研究者
相似试验
进行中（未招募）
不适用
Pharmacokinetics of anidulafungin (Ecalta ®) given intravenously as antifungal prophylaxis to recipients of an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or patients receiving intensive chemotherapy for AML-MDS who are at high risk for developing invasive fungal diseasePharmacokinetics of anidulafungin (Ecalta ®) given intravenously as antifungal prophylaxis to recipients of an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or patients receiving intensive chemotherapy for AML-MDS who are at high risk for developing invasive fungal diseaseMedDRA version: 9.1Level: LLTClassification code 10017533Term: Fungal infectionMedDRA version: 12.1Level: HLGTClassification code 10024324Term: LeukaemiasEUCTR2010-018752-27-NLRadboud University Nijmegen Medical Centre
已完成
4 期
Anidulafungin Pharmacokinetics Given as a Single Intravenous Dose to Obese Patients (ADOPT)Obesity MorbidNCT02021123Radboud University Medical Center8
已完成
2 期
Pharmacokinetics of Anidulafungin (Ecalta ®) Intravenous Given to Patients at High Risk for Developing Invasive Fungal DiseaseLeukemia, Myeloid, AcuteLeukemiaMyelodysplastic SyndromeNCT01249820Radboud University Medical Center26
进行中（未招募）
不适用
The pharmacokinetics of anidulafungin during continuous venovenous hemofiltratiointensive care patients with suspected or proven fungal infection, who undergo hemofiltrationMedDRA version: 9.1Level: LLTClassification code 10042941Term: Systemic fungal infection NOSEUCTR2008-007753-12-ATMUW, Universitätsklinik für Innere Medizin I, Abteilung für Infektionskrankheiten und Tropenmedizin
已完成
4 期
Anidulafungin pharmacokinetics given as a single intravenous dose to obese patients (ADOPT).Candidiasis / Fungal infections10017528NL-OMON40398niversitair Medisch Centrum Sint Radboud8